Moviprep

Caution! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Moviprep, powder for oral solution
Macrogol 3350 + anhydrous sodium sulfate + sodium chloride + potassium chloride + ascorbic acid + sodium ascorbate
Please read the leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms appear identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Moviprep is and what it is used for
2. Important information before taking Moviprep
3. How to take Moviprep
4. Possible side effects
5. How to store Moviprep
6. Contents of the pack and other information

1. What Moviprep is and what it is used for

Moviprep is a lemon-flavoured bowel cleansing medicine consisting of four sachets.
The pack contains two large sachets ("sachet A") and two small sachets ("sachet B"). All four sachets are required to complete a single treatment cycle.
Moviprep is intended for adults and is used to cleanse the intestines, thereby enabling their examination.
Moviprep causes emptying of the bowels; therefore, watery stools should be expected after taking it.

2. Important information before taking Moviprep

When not to take Moviprep:

• if the patient is allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has intestinal obstruction,
• if the patient has intestinal wall perforation,
• if the patient has gastric emptying disorders,
• if the patient has intestinal paralysis (often occurring after abdominal surgery),
• if the patient has phenylketonuria. This is an inherited inability of the body to process a specific amino acid. Moviprep contains a substance that is a source of phenylalanine,
• if the patient's body does not produce sufficient glucose-6-phosphate dehydrogenase,
• if the patient has toxic megacolon (a serious complication of acute colitis).

Warnings and precautions
If the patient's general health condition is poor or the patient suffers from a serious illness, they should be aware of possible adverse effects listed in section 4. In case of doubt, contact a doctor or pharmacist.
Before starting to take Moviprep, discuss this with a doctor or pharmacist if:

• the patient has a tendency to regurgitate swallowed drinks, food, or stomach acid, or has swallowing difficulties (see Moviprep with food and drink),
• the patient has kidney disease,
• the patient has been diagnosed with heart failure or heart diseases, including high blood pressure, irregular heartbeat, or palpitations,
• the patient has thyroid disorders,
• the patient is dehydrated,
• the patient is experiencing an acute flare-up phase of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Moviprep should not be administered to patients with impaired consciousness without medical supervision.
If, during the administration of Moviprep for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, contact a doctor or seek immediate medical assistance.

Children and adolescents
Moviprep should not be used in children and adolescents under 18 years of age.

Moviprep with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
If the patient is taking other oral medicines (e.g. oral contraceptive tablets), they should not be taken one hour before, during, or one hour after taking Moviprep, as otherwise these medicines may be flushed out of the gastrointestinal tract and may not work effectively.

Moviprep with food and drink
Do not consume any solid food from the moment you start taking Moviprep until the end of the procedure.
If the patient requires thickened liquids to safely swallow them, Moviprep may counteract the thickening effect.
During administration of Moviprep, drink large amounts of fluids. The fluid contained in the Moviprep solution does not replace regularly consumed fluids.

Pregnancy, breastfeeding, and fertility
There are no data on the use of Moviprep during pregnancy and breastfeeding; therefore, the medicine should be taken only if the doctor considers it necessary. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Moviprep has no influence on the ability to drive or operate machinery.

Moviprep contains sodium, potassium, and aspartame (a source of phenylalanine)
This medicine contains 8.4 g of sodium (the main component of table salt) in one treatment cycle (a treatment cycle consists of two liters of prepared Moviprep solution). This amount represents 420% of the recommended maximum daily sodium intake for an adult. This should be taken into account in patients on a sodium-controlled diet. Only part of the sodium is absorbed (up to 2.6 g in one treatment cycle).
This medicine contains 1.1 g of potassium in one treatment cycle (a treatment cycle consists of two liters of prepared Moviprep solution). This should be taken into account in patients with kidney function disorders or those on a potassium-controlled diet.
This medicine contains aspartame (a source of phenylalanine). It may be harmful to patients with phenylketonuria.

3. How to take Moviprep
Always take this medicine exactly as instructed by the doctor. In case of doubt, consult a doctor or pharmacist.
The recommended dose is two liters of solution prepared as follows:
The package contains two transparent sachets, each containing a pair of sachets: sachet A and sachet B. Each pair of sachets (A and B) should be dissolved in water to obtain one liter of solution. Thus, this package is sufficient to prepare two liters of Moviprep solution.
Before taking Moviprep, carefully read the instructions below. The patient must know:

• When to take Moviprep
• How to prepare Moviprep
• How to take Moviprep
• What to expect after taking the medicine

When to take Moviprep
This medicine should always be taken as described in the leaflet or as instructed by the doctor. In case of doubt, consult a doctor. Treatment with Moviprep must be completed before the procedure begins.
The medicine can be taken either in divided doses or as a single dose, as described below:

For procedures performed under sedation (general anesthesia):

1. Divided doses: one liter of Moviprep solution in the evening on the day before the procedure and one liter of Moviprep solution early in the morning on the day of the procedure. Ensure that intake of Moviprep, as well as other clear fluids, is completed at least two hours before the start of the procedure.
2. Single dose: two liters of Moviprep solution in the evening on the day before the procedure or two liters of Moviprep solution in the morning on the day of the procedure. Ensure that intake of Moviprep, as well as other clear fluids, is completed at least two hours before the start of the procedure.

For procedures performed without sedation (without general anesthesia):

1. Divided doses: one liter of Moviprep solution in the evening on the day before the procedure and one liter of Moviprep solution early in the morning on the day of the procedure. Ensure that intake of Moviprep, as well as other clear fluids, is completed at least one hour before the start of the procedure.
2. Single dose: two liters of Moviprep solution in the evening on the day before the procedure or two liters of Moviprep solution in the morning on the day of the procedure. Ensure that intake of Moviprep is completed at least two hours before the start of the procedure.
   Ensure that intake of other clear fluids is completed at least one hour before the start of the procedure.
   Important: Do not consume any solid food from the moment you start taking Moviprep until the end of the procedure.

How to prepare Moviprep

• Open one transparent sachet and remove sachets A and B.
• Add the contents of BOTH sachets A and B into a measuring jug with a capacity of at least 1 liter.
• Add water up to the 1-liter mark indicated on the jug and mix until the powder is completely dissolved. The Moviprep solution should be clear or slightly cloudy. This may take up to 5 minutes.

How to take Moviprep
The first liter of Moviprep solution should be consumed within one to two hours. The patient should aim to drink a full glass every 10–15 minutes.
When ready, prepare and drink the second liter of Moviprep solution made from the contents of sachets A and B from the remaining sachet.
During Moviprep administration, it is recommended to additionally drink one more liter of clear fluid to prevent thirst and dehydration. Suitable fluids include: water, light clear soups, fruit juices (without pulp), soft drinks, tea, or coffee (without milk). These drinks should be consumed no later than two hours before the procedure under general anesthesia and no later than one hour before the procedure without general anesthesia.

What to expect after taking the medicine
After starting to take the Moviprep solution, stay near a toilet. At some point, the patient will begin to pass watery stools. This is completely normal and indicates that the Moviprep solution is working. Bowel movements and the need to defecate will cease shortly after stopping intake.
Following these instructions will help cleanse the intestines, enabling successful completion of the procedure. After the last fluid intake, allow sufficient time for travel to the endoscopy unit.

Taking more than the recommended dose of Moviprep
Taking more than the recommended dose of Moviprep may lead to excessive diarrhea, which may result in dehydration. Drink large amounts of fluids, especially fruit juices. In case of doubt, contact a doctor or pharmacist.

Missing a dose of Moviprep
If a dose of Moviprep is missed, the patient should take it as soon as they realize the dose was missed. If several hours have passed since the scheduled dose time, consult a doctor or pharmacist.
If the patient is taking Moviprep in divided doses, it is very important to complete intake at least one hour before a procedure without general anesthesia or at least two hours before a procedure under general anesthesia.
If the patient is taking Moviprep as a single morning dose on the day of the procedure, it is very important to complete intake at least two hours before the procedure.
For any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Moviprep can cause adverse reactions, although not everyone experiences them.
A typical symptom after taking Moviprep is diarrhoea.
The patient should stop taking Moviprep and contact a doctor immediately if any of the following symptoms occur:

• rash or itching
• swelling of the face, ankles or other body parts
• palpitations
• significant fatigue
• shortness of breath

These are symptoms of a severe allergic reaction.
If no bowel movement occurs within 6 hours after taking Moviprep, the patient should stop taking the medicine and contact a doctor immediately.

Other adverse reactions:
Very common adverse reactions (occur in more than 1 in 10 people):
Abdominal pain, flatulence, fatigue, general malaise, anal pain, nausea, and fever.
Common adverse reactions (occur in up to 1 in 10 people):
Hunger, sleep disturbances, dizziness, headache, vomiting, indigestion, thirst, and chills.
Uncommon adverse reactions (occur in up to 1 in 100 people):
Discomfort, difficulty swallowing, and changes in liver function test results.

The following adverse reactions have also been observed, although data on their frequency are lacking: flatulence, transient increase in blood pressure, irregular heart rhythm or palpitations, dehydration, vomiting reflex, very low blood sodium levels which may lead to seizures, and changes in blood electrolyte levels, such as decreased bicarbonate levels, increased or decreased calcium levels, increased or decreased chloride levels, and decreased phosphate levels. Blood potassium and sodium levels may also decrease.
These reactions usually occur only during treatment. If they persist, medical advice should be sought.
Allergic reactions may cause skin rash, itching, skin redness or urticaria, swelling of hands, feet or ankles, headache, palpitations, and shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Moviprep

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. Note that the expiry date may differ between individual sachets.
The expiry date refers to the last day of the stated month.
Medicinal product in sachets: Store below 25°C.
After reconstitution: Store below 25°C. The solution may be stored in a refrigerator (2°C–8°C). Keep the solution covered.
Do not store the solution for longer than 24 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the package and other information

What Moviprep contains
Pouch A contains the following active substances:
Macrogol 3350 100 g
Anhydrous sodium sulfate 7.500 g
Sodium chloride 2.691 g
Potassium chloride 1.015 g
Pouch B contains the following active substances:
Ascorbic acid 4.700 g
Sodium ascorbate 5.900 g

Electrolyte ion concentration after dissolving both pouches in one litre of water:
Sodium
Chloride
Sulfate
Potassium
Ascorbate
181.6 mmol/l (of which no more than 56.2 mmol is absorbable)
59.8 mmol/l
52.8 mmol/l
14.2 mmol/l
29.8 mmol/l

The other ingredients are:
Lemon flavour (containing maltodextrin, citral, lemon oil, lemongrass oil, xanthan gum, vitamin E) and aspartame (E 951), acesulfame potassium (E 950) as sweeteners.
For further information, see section 2.

What Moviprep looks like and contents of the pack
The package contains two transparent bags, each containing one pair of pouches: pouch A and pouch B. Each pair of pouches (A and B) must be dissolved in one litre of water.
Moviprep, powder for oral solution in pouches, is available in packs containing 1 therapeutic set.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Austria, the country of export:
Norgine B.V.
Antonio Vivaldistraat 150
1083HP Amsterdam
The Netherlands

Manufacturer:
Recipharm Höganäs AB
Sporthallsvägen 6
Höganäs, 263 34
Sweden
Norgine Ltd.
New Road
Tir-y-Berth, Hengoed
Mid Glamorgan, CF82 8SJ
United Kingdom
SOPHARTEX
21 rue du Pressoir
28500 Vernouillet
France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in Austria, the country of export: 1-26774
Parallel Import Marketing Authorisation Number: 218/24

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland): MOVIPREP
Sweden: MOVPREP

The following information is intended exclusively for medical personnel and healthcare professionals:
Information intended exclusively for healthcare professionals:
Moviprep should be used with caution in very weak patients in poor general condition and in patients with clinical disorders such as:

• impaired gag reflex or tendency to choking or regurgitation
• disturbances of consciousness
• severe renal impairment (creatinine clearance < 30 ml/min)
• cardiac failure (NYHA class III or IV)
• in individuals at risk of arrhythmias, for example those being treated for cardiovascular diseases or thyroid disorders
• dehydration
• acute flare-up of severe inflammatory bowel disease

Dehydration or electrolyte disturbances must be corrected before administration of Moviprep.
Patients who are partially conscious or at risk of choking or regurgitation must remain under close supervision during administration of the medicinal product, especially when administered via nasogastric route.
Moviprep must not be administered to unconscious patients.